Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the
www.fepblue.org
website.
Atidarsagene autotemcel (Lenmeldy) may be considered medically necessary when
ALL
the following criteria are met:
-
The individual's age is less than 18 years;
and
-
The individual is screen and found to be negative for hepatitis B virus (HBV), hepatitis C virus (HCV), human T-lymphotrophic virus 1 & 2 (HTLV-1/HTLV-2), human immunodeficiency virus 1 & 2 (HIV-1/HIV-2), and mycoplasma infection before collection of cells for manufacturing;
and
-
The individual will not be administered vaccinations during the 6 weeks preceding the start of myeloablative conditioning, and until hematological recovery following treatment (Note: Where feasible, administer childhood vaccinations prior to myeloablative conditioning);
and
-
The individual risk factors for thrombosis as well as veno-occlusive disease have been evaluated prior to administration;
and
-
Prophylaxis for infection will be followed according to standard institutional guidelines;
and
-
The individual will be monitored for hematological malignancies periodically after treatment;
and
-
The individual will not receive prophylactic HIV anti-retroviral therapy for at least one-month preceding mobilization (Note: anti-retrovirals may interfere with manufacturing);
and
-
The individual will have mobilization of stem cells using granulocyte-colony stimulating factor (G-CSF with or without plerixafor);
and
-
Used as single agent therapy (Note: not inclusive of busulfan conditioning regimen);
and
-
The individual has not received a prior allogeneic stem cell transplant (or has, but is without evidence of residual donor cells present), and is a candidate for autologous stem cell transplantation (e.g., adequate renal and hepatic function);
and
-
The individual does not have a known 10/10 human leukocyte antigen matched related donor willing to participate in an allogeneic HSCT;
and
-
The individual has not received other gene therapy for MLD;
and
-
The individual has a confirmed diagnosis of MLD (also known as arylsulfatase A deficiency) as evidenced by the following biochemical and molecular markers:
-
Arylsulfatase A (ARSA) enzyme activity below the normal range in peripheral blood mononuclear cells-leukocytes or fibroblasts OR increased urinary excretion of sulfatides;
and
-
Presence of biallelic ARSA pathogenic mutation of known polymorphisms (Note: Individuals with novel mutations, a 24-hour urine collection must show elevated sulfatide levels);
and
- The individual has pre-symptomatic late infantile (PSLI), presymptomatic, early juvenile (PSEJ) or early symptomatic early juvenile (ESEJ) disease (Note: Requests for children with late juvenile form of the disease will be reviewed on a case-by-case basis).
Length of approval: One (1) treatment course (one (1) dose) and may not be renewed.
The use of Atidarsagene autotemcel (Lenmeldy) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.
Procedure Code
